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Featured Event

Roll up your sleeves for a two-day, introductory workshop on how to prepare an effective electronic Common Technical Document (eCTD) submission. This in-person workshop includes skill-building, interactive exercises, case studies and small group discussions.

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Our Global Community

Local or global—RAPS has you covered with offices in Washington, DC, Shanghai and Singapore. There are RAPS chapters in Canada, Israel, Switzerland, Taiwan and throughout the United States, and local networks in Australia, Belgium, Brazil, Germany, India, Mexico, The Netherlands, Poland and Singapore.

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Featured Article

A look at the blended approach and other options for an
outsourced pharmacovigilance model and their benefits for small pharmaceutical
companies. This article provides advice on the steps required to complete a
successful PV outsourcing project.

A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports.

The US Food and Drug Administration (FDA) is an agency which often courts controversy. But according to a new survey by the polling group Nielsen, the agency must be an equal opportunity offender, because it attracts fairly uniform—and high levels of—support from Democrats and Republicans alike.

Regulatory News

News for regulatory professionals, covering the latest from regulators, new and proposed legislation, research and studies, regulatory trends affecting the healthcare product industries, international standards and more.

A new study conducted by a team of researchers at Germany’s health technology assessment (HTA) body finds that publicly available clinical trial information is “insufficient” compared to full clinical study reports.

The US Food and Drug Administration (FDA) is an agency which often courts controversy. But according to a new survey by the polling group Nielsen, the agency must be an equal opportunity offender, because it attracts fairly uniform—and high levels of—support from Democrats and Republicans alike.

A rare disease advocacy network has applauded the European Medicines Agency’s (EMA) efforts to incentivize the development of treatments for rare diseases, but says the variance in treatment access across the EU is “unacceptable.”

Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often.

A dietary supplement firm long on the US Food and Drug Administration's (FDA) enforcement radar is again in the agency's sights after regulators claim they found fluoxetine, the active ingredient in Prozac, in one of the company's former fitness products.

Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year.

A US-based trade group wants to see the United States Trade Representative (USTR) pursue stricter limits on the ability of countries to bypass patent protection. In its Special 301 Submission 2015, the Pharmaceutical Research and Manufacturers of America (PhRMA) argues that compulsory licenses should only be issued in “exceptional situations,” where there is a pressing public health need.

US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs.

The US Department of Health and Human Services (DHHS) has declared that a strain of enterovirus now sweeping across the US has a high potential to cause a "public health emergency," thereby allowing the US Food and Drug Administration (FDA) to clear the use of drugs and diagnostic devices under special "emergency use" regulatory pathways.

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

The US Food and Drug Administration (FDA) said it will require manufacturers of multi-dose diabetes pen devices to label their products with more prominent warnings that patients should not share the devices.

In an effort to reduce its administrative burden, the European Medicines Agency (EMA) will soon require companies to use electronic forms for a number of application types. The move is part of a wider effort in the EU to transition to international and electronic standards.

The Therapeutic Goods Administration (TGA) this week issued a safety advisory over two smoking devices that bear strong resemblance to metered dose inhalers used to treat asthma and other medical conditions.